Substance Use Disorders (SUD)Phase 1NCT04232878
A Single Ascending Dose Trial of CVL-936 in Healthy Subjects
A Phase 1 study testing CVL-936 in people with Substance Use Disorders (SUD), run by Cerevel Therapeutics, LLC at 1 site in United States.
Trial summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders (SUD)
- What is being tested?
- CVL-936
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 21 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years
Who cannot join
- Subjects with a current history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine, hematological, immunological, psychiatric, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
- Subjects with epilepsy or a history of seizures
- Systolic supine blood pressure ≥130 mmHg and/or supine diastolic blood pressure ≥80 mmHg at Screening or Day -1, or orthostatic hypotension at Screening or Day -1.
- Subjects with a history of hypersensitivity to any dopamine-blocker medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute
Marlton, New Jersey, 08053
About this study
Official title: A Phase 1, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Ascending Doses of CVL-936 In Healthy Subjects
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.
- Conditions
- Substance Use Disorders (SUD)
- Being tested
- CVL-936, Matching Placebo
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-936Drug
CVL-936
Matching PlaceboDrug
Placebo matching CVL-936
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Group 1 Period 1: 0.5mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 1 Period 2:TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 1 Period 3:TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 2 Period 1:TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 2 Period 2:TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 2 Period 3:TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
| Active Comparator: Group 3: TBD mg CVL-936 | Active comparator | Oral suspension/solution Receives: Drug: CVL-936 |
| Placebo Comparator: Group 3: TBD mg Matching Placebo | Placebo comparator | Matching Placebo; Oral suspension/solution Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
Measured: At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF)
Measured: At the end of Period 3 (30 Days)
Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
Measured: At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in laboratory measures
Number of subjects with clinically significant changes in hematology, serum chemistry and urinalysis will be reported
Measured: At the end of Period 3 (30 Days)
Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Measured: At the end of Period 3 (30 Days)
Change from Baseline of Simpson-Angus Scale (SAS) Results
Evaluating Extrapyramidal symptoms using the SAS. The SAS consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
Measured: At the end of Period 3 (30 Days)
Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the subject is at rest, and the investigator also makes global judgments on the subject's dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status. The AIMS Movement Rating Score is defined as the sum of items 1 through 7 (ie, items 1 through 4, facial and oral movements; items 5 and 6, extremity movements; and item 7, trunk movements).
Measured: At the end of Period 3 (30 Days)
Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results
Evaluating Extrapyramidal symptoms using the BARS. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the subject, subjective distress due to akathisia, and global clinical assessment of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Measured: At the end of Period 3 (30 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start16 Dec 2019
- Primary completion6 Mar 2020
- Study completion21 May 2020
Why it stopped: Sufficient data has been obtained to meet current objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorders (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A sample size of 9 subjects per cohort has been chosen based on the need to minimize exposure of humans to CVL-936 and PF-06815106 and the requirement to provide adequate safety, tolerability, and PK information at each dose. Each cohort will be conducted as a crossover design with 3 periods and each cohort will have up to 6 subjects receiving CVL-936 and 3 subjects receiving placebo within each period, with a total of approximately 18 subjects if 2 cohorts complete or a total of approximately 27 subjects if 3 cohorts complete.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Leoni, MD, Study director, Cerevel Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232878
- Sponsor's protocol ID
- CVL-936-HV-001
- Status last verified
- Jun 2020
- First submitted
- 10 Jan 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Ascending Doses of CVL-936 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT04232878
- Acronym / sponsor ID
- CVL-936-HV-001
- Conditions
- Substance Use Disorders (SUD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sufficient data has been obtained to meet current objectives
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- Model description
- A sample size of 9 subjects per cohort has been chosen based on the need to minimize exposure of humans to CVL-936 and PF-06815106 and the requirement to provide adequate safety, tolerability, and PK information at each dose. Each cohort will be conducted as a crossover design with 3 periods and each cohort will have up to 6 subjects receiving CVL-936 and 3 subjects receiving placebo within each period, with a total of approximately 18 subjects if 2 cohorts complete or a total of approximately 27 subjects if 3 cohorts complete.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group 1 Period 1: 0.5mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 1 Period 2:TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 1 Period 3:TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 2 Period 1:TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 2 Period 2:TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 2 Period 3:TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
| Active Comparator: Group 3: TBD mg CVL-936 | Active comparator | Drug: CVL-936Oral suspension/solution |
| Placebo Comparator: Group 3: TBD mg Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo; Oral suspension/solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years
Key exclusion criteria (4 listed)
- Subjects with a current history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine, hematological, immunological, psychiatric, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
- Subjects with epilepsy or a history of seizures
- Systolic supine blood pressure ≥130 mmHg and/or supine diastolic blood pressure ≥80 mmHg at Screening or Day -1, or orthostatic hypotension at Screening or Day -1.
- Subjects with a history of hypersensitivity to any dopamine-blocker medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL-936CVL-936 | Drug | Active Comparator: Group 1 Period 1: 0.5mg CVL-936, Active Comparator: Group 1 Period 2:TBD mg CVL-936, Active Comparator: Group 1 Period 3:TBD mg CVL-936, Active Comparator: Group 2 Period 1:TBD mg CVL-936, Active Comparator: Group 2 Period 2:TBD mg CVL-936, Active Comparator: Group 2 Period 3:TBD mg CVL-936, Active Comparator: Group 3: TBD mg CVL-936 |
| Matching PlaceboPlacebo matching CVL-936 | Drug | Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo, Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo, Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo, Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo, Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo, Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo, Placebo Comparator: Group 3: TBD mg Matching Placebo |
Primary outcome
Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
Time frame: At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF)
Time frame: At the end of Period 3 (30 Days)
Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
Time frame: At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in laboratory measures
Time frame: At the end of Period 3 (30 Days)
Number of subjects with clinically significant changes in hematology, serum chemistry and urinalysis will be reported
Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At the end of Period 3 (30 Days)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Change from Baseline of Simpson-Angus Scale (SAS) Results
Time frame: At the end of Period 3 (30 Days)
Evaluating Extrapyramidal symptoms using the SAS. The SAS consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results
Time frame: At the end of Period 3 (30 Days)
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the subject is at rest, and the investigator also makes global judgments on the subject's dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status. The AIMS Movement Rating Score is defined as the sum of items 1 through 7 (ie, items 1 through 4, facial and oral movements; items 5 and 6, extremity movements; and item 7, trunk movements).
Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results
Time frame: At the end of Period 3 (30 Days)
Evaluating Extrapyramidal symptoms using the BARS. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the subject, subjective distress due to akathisia, and global clinical assessment of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Results and safety
The study was stopped early (reason given: Sufficient data has been obtained to meet current objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Leoni, MD study director
Cerevel Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVL-936 in people with Substance Use Disorders (SUD), run by Cerevel Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sufficient data has been obtained to meet current objectives). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs) (time frame: At the end of Period 3 (30 Days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.